VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM

K981700 · Origin Medsystems, Inc. · GCJ · May 29, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981700
• Device Name: VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM
• Applicant: Origin Medsystems, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 29, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vaso View™ Dissection/Vessel Harvesting System has applications in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients undergoing endoscopic surgery requiring tissue separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/ vessel harvesting along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall. The The VasoView™ Dissection/Vessel Harvesting System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

Device Story

Single-use, sterile dissection cannula used with 5mm extended length endoscope for minimally invasive surgery. Features tapered, clear tip for endoscopic visualization and tissue separation; elliptical bulb aids cavity creation; insufflation maintains cavity. Includes Origin BTT Port with valve body, internal flapper valve, and seal to prevent gas leakage during instrument insertion/withdrawal; converter doors accommodate various instrument diameters. Operated by surgeons in clinical settings to access vessels or anatomical structures. Provides physical access and visualization for vessel harvesting and tissue dissection. Benefits include reduced invasiveness compared to open procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design, material, and technological similarities to the predicate device.

Technological Characteristics

Single-use, sterile dissection cannula. Materials: Polycarbonate (cannula, bulb, manifold), Loctite™ adhesive. Features: Tapered clear tip, elliptical bulb, handle, and BTT Port with internal flapper valve/seal and converter doors. Energy source: Manual operation with insufflation. Connectivity: None. Sterilization: Sterile.

Indications for Use

Indicated for patients undergoing endoscopic vessel harvesting for arterial bypass or endoscopic surgery requiring tissue separation of extraperitoneal, subcutaneous extremity, or thoracic spaces. Includes saphenous vein/femoral vessel harvesting and exposure/dissection of chest wall structures (nerves, blood vessels) external to the parietal pleura. Contraindicated for patients where endoscopic surgery is contraindicated.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• ORIGIN System VasoView™ Balloon Dissection System (K964171)

Submission Summary (Full Text)

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Guidant Corporation/ORIGIN "Special 510{k): Device Modification" VasoView ™ Dissection/Vessel Harvesting System

K981700

Class II

### MAY 2 9 1998

:

## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.

#### 21 CFR §807.92 a(1)

Guidant Corporation ORIGIN® Medsystems, Inc. Submitter: 135 Constitution Avenue Menlo Park, CA 94025 [phone] contact person: Cynthia G. Royster date prepared: May 19, 1998

#### 21 CFR §807.92 a(2)

VasoView™ Dissection/Vessel Harvesting System Trade name:

| Common name: | Dissection Cannula |
|----------------------|--------------------|
| Classification name: | Distention Cannula |

### 21 CFR §807.92 a(3)

Identification of predicate(s): Substantial equivalence for the VasoView™ Dissection/Vessel Harvesting System is based on its similarities to predicate device : the ORIGIN System VasoView™ Balloon Dissection System. It shares similar material, and identical technological characteristics as the predicate device. It also is identical in intended use.

## 21 CFR §807.92 a(4)

Device Description-parts and function/concept: The VasoView™ Dissection/Vessel Harvesting System is a single-use device provided sterile. It is designed to be used in conjunction with a 5mm Extended Length Endoscope. The cannula has a tapered tip for tissue separation. Initial tissue separation is performed under endoscopic visualization with the clear tapered tip. The elliptical bulb aids tissue separation, and insufflation holds open the cavity created.

The cannula tip may also be used for dissection and isolation of structures in the cavity. This tip is clear to allow for endoscopic visualization during tunneling. A handle is provided to assist with advancement of the cannula.

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KYA | 100 Guidant Corporation/ORIGIN "Special 510(k): Device Modification"

VasoView ™ Dissection/Vessel Harvesting System

Class II

The device is configured to accept a 5mm endoscope through the inner lumen of the cannula.

The Origin BTT Port is used to provide a port of access for insertion of endoscopic instruments into an extremity or extraperitoneal space. The device consists of a valve body assembly with a balloon on the sleeve. The valve body assembly contains an internal flapper valve and seal to prevent gas leakage when instruments are inserted or withdrawn. It also includes built-in converter doors to allow insertion of instruments of different diameters than the main seal. The external distal end of the sleeve has a balloon. A 30cc syringe is provided for inflation/deflation of the balloon.

Device Description-materials/physical properties: a table of the patient contact components, with their respective materials, is provided below.

| Component Name | Patient Contact | Material | Predicate |
|-----------------|-----------------|---------------|----------------------------------------------------|
| Cannula | yes | Polycarbonate | Vaso View Balloon<br>Dissection Cannula<br>K964171 |
| Elliptical Bulb | yes | Polycarbonate | Vaso View Balloon<br>Dissection Cannula<br>K964171 |
| Adhesive | yes | Loctite™ | Vaso View Balloon<br>Dissection Cannula<br>K964171 |
| Manifold | yes | Polycarbonate | Vaso View Balloon<br>Dissection Cannula<br>K964171 |

The listed parts are currently being used in existing ORIGIN products, and therefore have been cleared for biocompatibility (safety) and effectiveness.

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Guidant Corporation/ORIGIN "Special 510(k): Device Modification" Vaso View ™ Dissection/Vessel Harvesting System

Class II

#### 21 CFR §807.92 a(5)

Intended use and relationship to predicate(s): The Vaso View™ Dissection/Vessel Harvesting System has applications in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients undergoing endoscopic surgery requiring tissue separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/ vessel harvesting along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The The VasoView™ Dissection/Vessel Harvesting System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

#### CFR §807.92 a(6)

Technological characteristics and relationship to predicate(s): The VasoView™ Dissection/Vessel Harvesting System is substantially equivalent to the Vaso View Balloon Dissection Cannula previously cleared product. The VasoView™ Dissection/Vessel Harvesting System shares the identical function, technological characteristics and similar materials as the

# 21 CFR §807.92 b

predicate device.

This submission's determination of substantial equivalence is based on similarities to the predicate devices in terms of intended uses, materials, and technological characteristics.

### 21 CFR §807.92 c

In accordance with the specifications of this subsection, this summary (3 pages) is its own section, and has been clearly identified as such.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 1998

Ms. Cynthia G. Royster Manager Regulatory Affairs ORIGIN Medsystems, Incorporated 135 Constitution Drive Menlo Park, California 94025

Re : K981700 Vaso-View ™ Dissection/Vessel Harvesting Trade Name: System Requlatory Class: II Product Code: GCJ Dated: May 5, 1998 May 14, 1998 Received:

Dear Ms. Royster:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Royster

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| | K981700 |
|---------------------------|---------|
| 510(k) Number (if known): | K964171 |

Vaso View™Balloon Dissection System Device Name: has applications in minimally invasive surgery Indications For Use: allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients undergoing endoscopic surgery requiring tissue separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Optional Format 1-2-96) 4016